Study set-up

IMPACTT – to study if PsAer-IgY will postpone Pseudomonas infection and diminish use of antibiotics

The objective of the IgY-clinica (clinical trial III) is to investigate whether gargling with IgY postpones Pseudomonas lung infections in patients with cystic fibrosis. Long-term phase II studies have shown that daily gargling with IgY prolongs time between infections with PA, postpones start of chronic PA infections, and reduces use of antibiotics.  Anti-Pseudomonas IgY are antibodies from hens egg yolk that are supposed to specifically react with Pseudomonas aeruginosa. Gargling with IgY produces a "barrier" in the oropharynx which could prevent infection with this bacterium in the lower airways.

IMPACTT – a pan-European approach

Cooperation Partners from 7 European countries are working together to implement the clinical trial to investigate the efficacy of IgY gargling solution. The IgY gargling solution is produced in Sweden and is finally labeled in Germany. From Germany the medication is shipped to the participating sites. At present more than 20 cystic fibrosis centers from Germany, Sweden, Italy, Belgium Ireland and Czech Republic have given their consent to participate in the study. More than 180 patients will be asked to participate in the study.

IMPACTT – easy to perform

The study can be integrated into the routine treatment of cystic fibrosis patients. The patients come to their CF-site as usual every 3 months and give a sputum and sometimes a blood sample to be investigated in the central laboratory in Copenhagen that investigates whether there is an infection with Pseudomonas or not. Therefore, the effort of the study for the sites is mainly to document the patient data. Patients will stay in the study until their next positive Pseudomonas culture or maximal for 2 years. Further information can be found in the study synopsis.

IMPACTT – low risk of adverse events

Long-term phase II studies have shown that daily gargling with IgY prolongs time between infections with PA, postpones start of chronic PA infections, and reduces the use of antibiotics.

The risk of adverse events is very low. Hoever, as  IgY is an extract from egg yolk of vaccinated hens, those patients with allergies against eggs should not use the gargling solution.

IMPACTT – a treatment option also for children with cystic fibrosis?

IgY can be used from 5 years on - the patients only have to be able to gargle. This is very important, because Pseudomonas infections occur early in life of cystic fibrosis patients.

IMPACTT – when will we know?

recruitment of patients started in November 2011. In Germany, Belgium, Sweden, Italy and Ireland the study has been approved by competent authority and the respective ethical committees. The end of recruitment period is planned for June 2014. Accordingly, end of the study (last patient out) is 2 years later. Analysis of data will follow so that first data should be available at the end of 2016.